(59 days)
BioSieve™ Dx Marijuana Test Panel 20 is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Marijuana in human urine at the cutoff concentrations of 20 ng/mL. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only.
BioSieve™ Dx Marijuana Test Strip 20 is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Marijuana in human urine at the cutoff concentrations of 20 ng/mL.
The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only.
BioSieve™ Dx Marijuana Test Panel 50 is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Marijuana in human urine at the cutoff concentrations of 50 ng/mL. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only.
BioSieve™ Dx Marijuana Test Strip 50 is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Marijuana in human urine at the cutoff concentrations of 50 ng/mL.
The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only.
BioSieve™ Marijuana Test Panel 50 is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Marijuana in human urine at the cutoff concentrations of 50 ng/mL.
The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only.
BioSieve™ Marijuana Test Strip 50 is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Marijuana in human urine at the cutoff concentrations of 50 ng/mL.
The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only.
The BioSieve™ Marijuana Test Panel (Strip) and the BioSieve™ Dx Marijuana Test Panel (Strip) tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of Marijuana in human urine. The products are single-use in vitro diagnostic devices. Each test kit contains a Test Device and a package insert. Each test device is sealed with a desiccant in an aluminum pouch.
The provided document describes the BioSieve™ Marijuana Test Panel and Test Strip devices for qualitative detection of Marijuana in human urine. Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" for the overall device performance in a consolidated table, but rather presents performance characteristics of the device. From the precision study, it can be inferred that the device is expected to correctly identify drug-free samples and samples significantly above the cutoff, while showing a degree of variability around the cutoff. The provided precision data and the results of the comparison studies (with LC/MS) serve as the device's reported performance against implied accuracy and consistency expectations.
Inferred Acceptance Criteria / Performance Goals (based on Precision Study and Comparison Studies):
| Performance Characteristic | Acceptance Criteria (inferred) | Reported Device Performance (Summary) |
|---|---|---|
| Precision | Consistent results for samples well below and well above the cutoff. Some variability allowed around the cutoff concentrations (e.g., -25% to +25% of cutoff). Specifically, samples at -100%, -75%, -50% cut off should be negative, and samples at +50%, +75%, +100% cut off should be positive. Samples at -25% and +25% should show a mix of results, crossing the cutoff. This is implied by the study design and typical expectations for qualitative immunoassay cutoffs. | For 20 ng/mL Cut-off (Panel & Strip, across 3 lots): |
| -100%, -75%, -50% cutoff: 100% negative. | ||
| +50%, +75%, +100% cutoff: 100% positive. | ||
| Results around cutoff (-25%, cutoff, +25%) show expected mixed results (e.g., at cutoff, 32-37 positive, 23-28 negative). | ||
| For 50 ng/mL Cut-off (Panel & Strip, across 3 lots): | ||
| -100%, -75%, -50% cutoff: 100% negative. | ||
| +50%, +75%, +100% cutoff: 100% positive. | ||
| Results around cutoff (-25%, cutoff, +25%) show expected mixed results (e.g., at cutoff, 22-38 negative, 22-38 positive). | ||
| Accuracy (Comparison to LC/MS) | High agreement with LC/MS, especially for samples far from the cutoff. Close agreement for samples near the cutoff, while acknowledging some inherent variability in qualitative tests at the cutoff. | For 20 ng/mL Cut-off (Strip & Panel): |
| High agreement for drug-free, low negative, and high positive samples. Mixed results for near-cutoff negative and positive samples, with some discordant results (false positives and false negatives relative to LC/MS at/near cutoff). | ||
| For 50 ng/mL Cut-off (Strip & Panel): | ||
| Similar high agreement for drug-free, low negative, and high positive samples, with expected mixed and discordant results around the cutoff. | ||
| Interference | No interference from common substances within specified concentrations. | No interference observed from 70+ substances at tested concentrations (e.g., 100µg/mL for most, 1% ethanol, 100 mg/dL albumin). |
| Specificity (Cross-Reactivity) | Predictable cross-reactivity with structurally similar compounds, with 100% cross-reactivity for the target analyte at the cutoff. Other cannabinoids show varying degrees of cross-reactivity (e.g., 1% for 11-Hydroxy-Δ9-Tetrahydrocannabinol). | Confirmed: 100% cross-reactivity for 11-nor-Δ9-THC-9-COOH and 11-Nor-Δ8-Tetrahydrocannabinol-9-COOH at respective cutoffs. Low cross-reactivity (0.5% - 1%) for Δ8-Tetrahydrocannabinol, Δ9-Tetrahydrocannabinol, and 11-Hydroxy-Δ9-Tetrahydrocannabinol. No cross-reactivity for Cannabinol and Cannabidiol at 100000 ng/mL. |
| Effect of Urine Specific Gravity & pH | No effect on accuracy within specified ranges. | No effect on accuracy/precision for specific gravity (1.000-1.035) and pH (4-9) at +/- 25% (or +/- 50%) cutoff levels. |
| Stability | Stable for a specified duration under defined storage conditions. | 24 months at 4-30°C based on accelerated and real-time stability studies. |
| Lay-user Comprehension | Instructions for use are easy to understand and follow, leading to correct test interpretation. | All participants found instructions easy to understand. Flesch-Kincaid read-ability score of Grade Level 7. Overall high percentage of correct results (95-100%) by lay users, with minor exceptions at -25% and +25% cutoff. |
2. Sample Size Used for the Test Set and Data Provenance
-
Precision Study Test Set:
- For each of the four device types (20 ng/mL Strip, 20 ng/mL Panel, 50 ng/mL Strip, 50 ng/mL Panel), 9 concentrations were tested (ranging from -100% cutoff to +100% cutoff).
- For each concentration, tests were performed two runs per day at each site for each of 3 lots for 10 days.
- This equates to: 9 concentrations * 2 runs/day * 3 sites * 3 lots * 10 days = 1620 tests per device type across all concentrations.
- Data Provenance: The document does not specify the country of origin for the samples or the study sites. It implies prospective testing as samples were "prepared by spiking 11-Nor-△9-THC-9-COOH in drug-free urine samples" and confirmed by LC/MS.
-
Comparison Studies Test Set (Algorithm Only/Standalone):
- For each of the four device types (20 ng/mL Strip, 20 ng/mL Panel, 50 ng/mL Strip, 50 ng/mL Panel), 80 unaltered urine samples were used.
- These 80 samples consisted of 40 negative and 40 positive samples, categorized further into: Drug-Free, Low Negative, Near Cutoff Negative, Near Cutoff Positive, and High Positive.
- Data Provenance: The document does not specify the country of origin of these "unaltered urine samples." It implies these are retrospective samples as they were blind-labeled and compared to LC/MS results.
-
Lay-user Study Test Set:
- 280 lay persons participated.
- Urine samples were prepared at 7 concentrations (-100%, -75%, -50%, -25%, +25%, +50%, +75% of 50 ng/mL cutoff).
- Each concentration used 20 samples.
- Each participant was given 1 blind-labeled sample. This means a total of 7 concentrations * 20 samples/concentration = 140 samples were tested across the 280 lay persons (since each person tested only one sample).
- Data Provenance: The document does not specify the country of origin. The samples were "prepared by spiking 11-Nor-△9-THC-9-COOH into drug free-pooled urine specimens," indicating prospective preparation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Precision and Comparison Studies: The ground truth for spiked samples (-100% cutoff to +100% cutoff for precision, and the various categories for comparison studies) was established by LC/MS (Liquid Chromatography-Mass Spectrometry). This is a highly accurate and widely accepted analytical method. The document does not mention human experts establishing this ground truth; the instrument itself provides the "truth."
- Lay-user Study: The ground truth for the lay-user study samples was also established by LC/MS confirming the drug concentrations after spiking.
4. Adjudication Method for the Test Set
- Precision Study: The results are presented as counts of positive/negative readings. No explicit adjudication method (like 2+1) is mentioned, as is common for analytical precision studies where each test's outcome is recorded.
- Comparison Studies: The individual operators' results (positive/negative) were directly compared to the LC/MS results. Discordant results are individually listed against the LC/MS result. There is no mention of an adjudication process among the operators.
- Lay-user Study: The lay users' obtained results (positive/negative) were compared against the LC/MS confirmed drug concentration of the sample they tested. No adjudication is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC comparative effectiveness study was done, as this device is a standalone in-vitro diagnostic test kit (Strip/Panel), not an AI-assisted diagnostic tool for human readers. Therefore, there is no AI component, and no improvement effect size for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, standalone performance was evaluated by human observers interpreting the test results visually.
- The "Comparison Studies" section evaluates the device's performance by having six operators visually interpret the results of the strips/panels and compare them against LC/MS ground truth. This effectively determines the device's accuracy in a standalone setting (device + human interpretation) for laboratory professional users.
- The "Lay-user study" also evaluates the standalone performance by 280 lay persons visually interpreting the results.
7. The type of ground truth used
- The primary ground truth used for establishing drug concentrations and confirming results was LC/MS (Liquid Chromatography-Mass Spectrometry). This is considered a highly definitive analytical method for confirming drug presence and concentration.
8. The sample size for the training set
- The document does not mention a "training set" in the context of machine learning or AI. This is a traditional in-vitro diagnostic device (immunoassay) and therefore does not involve machine learning models that require training data. All samples described are used for performance validation and testing.
9. How the ground truth for the training set was established
- As there is no mention of a "training set" for a machine learning model, this question is not applicable to the described device. The samples used for performance evaluation (precision, comparison, lay-user studies) had their ground truth established by LC/MS confirmation of spiked drug concentrations or by direct LC/MS reference for unaltered urine samples.
§ 862.3870 Cannabinoid test system.
(a)
Identification. A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.(b)
Classification. Class II (special controls). A cannabinoid test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).